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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Boston Scientific: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Agency Publication Date: April 1, 2020
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Affected Products

Product: Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit

Lot Numbers: 24423656, 24423820, 24424087, 24427952, 24427959, 24428330, 24430010, 24437882, 24440182, 24440998, 24444952, 24446611, 24447516, 24447658, 24447722, 24447735, 24451828, 24452126, 24452132, 24452266, 24454238, 24455297, 24455381, 24455732, 24460452, 24460458, 24466032, 24487805, 24493956, 24494611, 24498583, 24498730, 24498732, 24499924, 24501439, 24506583, 24563429, 24563891, 24564727, 24564729, 24569684, 24570465, 24571203, 24579763, 24599358, 24609013, 24609991, 24614307, 24615296, 24620493, 24621357, 24621789, 24622541, 24623111, 24623117, 24623321, 24623461, 24623472, 24640257, 24661651, 24662199, 24663152, 24663562, 24663570, 24665001, 24665005, 24665100, 24665108, 24665990, 24666401, 24670677, 24672232, 24672553, 24678045, 24678047, 24681044, 24699798, 24700605, 24702016, 24708365, 24708371, 24709540, 24709550, 24710261, 24716280, 24716623, 24719303, 24723783, 24724284, 24732445, 24732731, 24738283, 24751717, 24756104, 24758578, 24763250, 24765356, 24766287, 24766401, 24772737, 24773528

Lot Numbers:
Numbers
Product: Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit

Lot Numbers: 24484631, 24494135, 24494288, 24533782, 24584655, 24617736, 24625474, 24665994, 24723912

Lot Numbers:
Numbers
Product: Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit

Lot Numbers: 24501748, 24506585, 24507390, 24507747, 24517205, 24517209, 24517211, 24526341, 24576484, 24576569, 24577900, 24579133, 24580102, 24583255, 24585905, 24586401, 24616721, 24617337, 24618334, 24724936, 24732742, 24737184, 24739802, 24790717, 24805720, 24860825, 24868932

Lot Numbers:
Numbers
Product: Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit

Lot Numbers: 24538844, 24647121

Lot Numbers:
Numbers
Product: Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110

Lot Numbers: 24795838

Lot Numbers:
Numbers
Product: Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110

Lot Number: 24835477 (edited 1/13/2021)

Lot Numbers:
Number
Product: Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)

Lot Number: 24958079 (edited 1/13/2021)

Lot Numbers:
Number
Product: Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080

Lot Numbers: 24879999, 25021676

Lot Numbers:
Numbers
Product: Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080

Lot Numbers: 24755840

Lot Numbers:
Numbers
Product: Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080

Lot Numbers: 24724232

Lot Numbers:
Numbers
Product: Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080

Lot Numbers: 24755842

Lot Numbers:
Numbers
Product: Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080

Lot Numbers: 24749818, 24913418

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85227
Status: Active
Manufacturer: Boston Scientific
Manufactured In: United States
Units Affected: 12 products (25,956; 1,785; 5,565; 225; 91 units; 32; 5 units; 2 units; 57 units; 50 units; 40 units; 19 units)
Agency Last Updated: January 13, 2021

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.